KR101659983B1 - 용융 압출된 방출 제어용 약학 조성물, 및 이를 포함하는 경구용 제제 - Google Patents

용융 압출된 방출 제어용 약학 조성물, 및 이를 포함하는 경구용 제제 Download PDF

Info

Publication number: KR101659983B1
Authority: KR; South Korea
Prior art keywords: weight; water; polyvinyl acetate; pellet; release
Prior art date: 2012-12-31

Application number

KR1020120158570A

Other languages

English (en)

Korean (ko)

Other versions

KR20140087847A (ko

Inventor

박상엽

임혜정

김경희

Original Assignee

주식회사 삼양바이오팜

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

2012-12-31

Filing date

2012-12-31

Publication date

2016-09-26

2012-12-31 Application filed by 주식회사 삼양바이오팜 filed Critical 주식회사 삼양바이오팜

2012-12-31 Priority to KR1020120158570A priority Critical patent/KR101659983B1/ko

2013-12-20 Priority to PCT/KR2013/011972 priority patent/WO2014104670A1/fr

2013-12-20 Priority to CN201380072515.6A priority patent/CN105025882B/zh

2013-12-20 Priority to JP2015550303A priority patent/JP6170569B2/ja

2013-12-20 Priority to US14/758,258 priority patent/US10143659B2/en

2013-12-20 Priority to EP13869605.9A priority patent/EP2939663B1/fr

2014-07-09 Publication of KR20140087847A publication Critical patent/KR20140087847A/ko

2016-09-26 Application granted granted Critical

2016-09-26 Publication of KR101659983B1 publication Critical patent/KR101659983B1/ko

Classifications

- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

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Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Medicinal Chemistry (AREA)
Pharmacology & Pharmacy (AREA)
Life Sciences & Earth Sciences (AREA)
Animal Behavior & Ethology (AREA)
General Health & Medical Sciences (AREA)
Public Health (AREA)
Veterinary Medicine (AREA)
Epidemiology (AREA)
Engineering & Computer Science (AREA)
Bioinformatics & Cheminformatics (AREA)
Inorganic Chemistry (AREA)
Psychiatry (AREA)
Biomedical Technology (AREA)
Neurology (AREA)
Neurosurgery (AREA)
Chemical Kinetics & Catalysis (AREA)
General Chemical & Material Sciences (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Organic Chemistry (AREA)
Medicinal Preparation (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

KR1020120158570A 2012-12-31 2012-12-31 용융 압출된 방출 제어용 약학 조성물, 및 이를 포함하는 경구용 제제 KR101659983B1 (ko)

Priority Applications (6)

Application Number	Priority Date	Filing Date	Title
KR1020120158570A KR101659983B1 (ko)	2012-12-31	2012-12-31	용융 압출된 방출 제어용 약학 조성물, 및 이를 포함하는 경구용 제제
PCT/KR2013/011972 WO2014104670A1 (fr)	2012-12-31	2013-12-20	Composition pharmaceutique extrudée par fusion permettant de contrôler la libération, et médicament administré par voie orale contenant ladite composition
CN201380072515.6A CN105025882B (zh)	2012-12-31	2013-12-20	熔融挤出而成的控释药物组合物及包含其的口服制剂
JP2015550303A JP6170569B2 (ja)	2012-12-31	2013-12-20	溶融押出された放出制御用薬学組成物、およびこれを含む経口用製剤
US14/758,258 US10143659B2 (en)	2012-12-31	2013-12-20	Melt-extruded release controlled pharmaceutical composition and oral dosage form comprising the same
EP13869605.9A EP2939663B1 (fr)	2012-12-31	2013-12-20	Composition pharmaceutique à libération controlée extrudée à chaud, et médicament administré par voie orale contenant ladite composition

Applications Claiming Priority (1)

Application Number	Priority Date	Filing Date	Title
KR1020120158570A KR101659983B1 (ko)	2012-12-31	2012-12-31	용융 압출된 방출 제어용 약학 조성물, 및 이를 포함하는 경구용 제제

Related Child Applications (1)

Application Number	Title	Priority Date	Filing Date
KR1020160112310A Division KR101757147B1 (ko)	2016-09-01	2016-09-01	용융 압출된 방출 제어용 약학 조성물의 제조방법

Publications (2)

Publication Number	Publication Date
KR20140087847A KR20140087847A (ko)	2014-07-09
KR101659983B1 true KR101659983B1 (ko)	2016-09-26

Family

ID=51021651

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
KR1020120158570A KR101659983B1 (ko)	2012-12-31	2012-12-31	용융 압출된 방출 제어용 약학 조성물, 및 이를 포함하는 경구용 제제

Country Status (6)

Country	Link
US (1)	US10143659B2 (fr)
EP (1)	EP2939663B1 (fr)
JP (1)	JP6170569B2 (fr)
KR (1)	KR101659983B1 (fr)
CN (1)	CN105025882B (fr)
WO (1)	WO2014104670A1 (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
CN105412039A (zh) *	2015-12-07	2016-03-23	青岛正大海尔制药有限公司	一种琥珀酸呋罗曲坦控释片及其制备方法
WO2019193488A1 (fr)	2018-04-06	2019-10-10	Capsugel Belgium Nv	Procédé de séchage par pulvérisation pour des particules à faible rapport d'aspect comprenant du poly[(méthacrylate de méthyle)-co-(acide méthacrylique)]
JP7338424B2 (ja)	2019-11-22	2023-09-05	株式会社Ihi	金属部材の熱影響部角度推定方法
JP7338423B2 (ja)	2019-11-22	2023-09-05	株式会社Ihi	アーク溶け込み深さ推定方法
CN110917175A (zh) *	2019-12-05	2020-03-27	广东东阳光药业有限公司	一种美托洛尔缓释组合物及其制备方法

Citations (1)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO2010009900A1 (fr)	2008-07-25	2010-01-28	Krka, D.D. Novo Mesto	Composition de palipéridone comprenant des particules de matrice solide

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
DE4031881C2 (de)	1990-10-08	1994-02-24	Sanol Arznei Schwarz Gmbh	Lösungsmittelfreie, oral zu verabreichende pharmazeutische Zubereitung mit verzögerter Wirkstoffreisetzung und Verfahren zu deren Herstellung
US5965161A (en) *	1994-11-04	1999-10-12	Euro-Celtique, S.A.	Extruded multi-particulates
EP2272536B1 (fr)	1996-06-26	2016-05-04	Board of Regents, The University of Texas System	Formulation pharmaceutique extrudable thermofusible
FR2795326B1 (fr) *	1999-06-28	2001-08-31	Adir	Composition pharmaceutique solide thermoformable a liberation controlee
CA2400567C (fr)	2000-02-08	2008-01-15	Euro-Celtique S.A.	Formes orales inviolables d'agonistes de l'opioide
KR100411195B1 (ko)	2000-09-26	2003-12-18	한국화학연구원	케토롤락 트로메타민이 함유된 서방형 펠렛
DE10353196A1 (de)	2003-11-13	2005-06-16	Röhm GmbH & Co. KG	Mehrschichtige Arzneiform mit einer die Abgabe einer modulatorischen Substanz beeinflussenden Matrix
TWI350762B (en)	2004-02-12	2011-10-21	Euro Celtique Sa	Particulates
JP4971159B2 (ja)	2004-08-13	2012-07-11	ベーリンガーインゲルハイムインターナショナルゲゼルシャフトミットベシュレンクテルハフツング	プラミペキソール又はその薬学的に許容しうる塩を含有する徐放性ペレット製剤、その製法及び使用
CN101170997A (zh)	2005-05-10	2008-04-30	诺瓦提斯公司	改进释放的泛昔洛韦药物组合物
US20090317355A1 (en) *	2006-01-21	2009-12-24	Abbott Gmbh & Co. Kg,	Abuse resistant melt extruded formulation having reduced alcohol interaction
CN101370480A (zh) *	2006-02-03	2009-02-18	赢创罗姆有限责任公司	含有由聚合物和在水中溶解较差的活性成分组成的混合物的药物组合物
KR100798730B1 (ko)	2006-06-12	2008-01-29	신풍제약주식회사	록소프로펜 또는 잘토프로펜 함유 제어방출성 제제 및 그의제조방법
WO2010026467A2 (fr) *	2008-09-04	2010-03-11	Torrent Pharmaceuticals Ltd.	Forme pharmaceutique à libération prolongée de principe actif hautement soluble

2012
- 2012-12-31 KR KR1020120158570A patent/KR101659983B1/ko active IP Right Grant
2013
- 2013-12-20 US US14/758,258 patent/US10143659B2/en active Active
- 2013-12-20 EP EP13869605.9A patent/EP2939663B1/fr active Active
- 2013-12-20 WO PCT/KR2013/011972 patent/WO2014104670A1/fr active Application Filing
- 2013-12-20 CN CN201380072515.6A patent/CN105025882B/zh active Active
- 2013-12-20 JP JP2015550303A patent/JP6170569B2/ja active Active

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO2010009900A1 (fr)	2008-07-25	2010-01-28	Krka, D.D. Novo Mesto	Composition de palipéridone comprenant des particules de matrice solide

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
Bulletin of Faculty of Pharmacy, Cairo University (2012) 50, 147-159 (온라인 공개 2012. 8. 23.).*
International Journal of Pharma and Bio Sciences V1(2) 2010 1-13.*
Pharm Res. 2003, 20(12):1970-1976

Also Published As

Publication number	Publication date
CN105025882B (zh)	2018-05-22
EP2939663A1 (fr)	2015-11-04
JP2016504349A (ja)	2016-02-12
JP6170569B2 (ja)	2017-07-26
WO2014104670A1 (fr)	2014-07-03
KR20140087847A (ko)	2014-07-09
CN105025882A (zh)	2015-11-04
US20160213621A1 (en)	2016-07-28
US10143659B2 (en)	2018-12-04
EP2939663B1 (fr)	2018-09-05
EP2939663A4 (fr)	2016-09-21

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CA2542836A1 (fr)	2005-05-12	Preparations pharmaceutiques contenant de la quetiapine
AU2004312059A1 (en)	2005-07-21	Atomoxetine formulations
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KR20080026754A (ko)	2008-03-26	생물학적 활성성분을 함유하는 방출 제어형 입자, 및 이의제조방법
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US20180280364A1 (en)	2018-10-04	Pharmaceutical compositions of sodium picosulfate, magnesium oxide and citric acid
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Legal Events

Date	Code	Title
2014-03-11	A201	Request for examination
2015-09-10	E902	Notification of reason for refusal
2015-11-10	AMND	Amendment
2016-03-24	E601	Decision to refuse application
2016-05-24	AMND	Amendment
2016-06-21	X701	Decision to grant (after re-examination)
2016-09-01	A107	Divisional application of patent
2016-09-20	GRNT	Written decision to grant